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Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties (DECADES)

Primary Purpose

Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated Psychology Services
Notification of Subspecialist
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients seen at the pediatric GI office who are screened for anxiety and depression as part of usual care.

Exclusion Criteria:

  • Patients over the age of 18 or under the age of 10.

Sites / Locations

  • Indiana University Health North Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual Subspecialty Care

Integrated Psychology Care

Arm Description

Once a subject is screened positive for anxiety or depression, the subspecialty provider is informed of the positive screen, and left to manage or refer the condition as per usual care by that provider. Intervention: Depression / anxiety screen + clinician informed.

Once a subject is screened positive for anxiety or depression, an automated psychology referral occurs, in addition to any intervention determined by the subspecialty provider. Intervention: Depression / anxiety screen + clinician informed + automated psychologist visit.

Outcomes

Primary Outcome Measures

Quality of life (baseline)
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)
Quality of life (followup)
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)

Secondary Outcome Measures

Utilization of endoscopy
The investigators will compare the use of endoscopy, radiologic testing, laboratory testing, emergency department utilization, and repeat gastroenterology outpatient visits. Frequency of each of these will be compared between control and intervention arms.
Utilization of radiologic testing
The electronic medical record will be queried by the RA and the total number of radiologic tests ordered over 6 months will be computed.
Utilization of laboratory testing
The electronic medical record will be queried by the RA and the total number of laboratory tests ordered over 6 months will be computed.
Utilization of emergency department visits
The electronic medical record will be queried by the RA and the total number of emergency department visits over 6 months will be computed.
Utilization of outpatient gastroenterology
The electronic medical record will be queried by the RA and the total number of outpatient gastroenterology visits over 6 months will be computed.

Full Information

First Posted
June 19, 2015
Last Updated
August 19, 2022
Sponsor
Indiana University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT02773706
Brief Title
Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties
Acronym
DECADES
Official Title
Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The DECADES trial seeks to determine the comparative effectiveness of specialist-centered management of anxiety and depression vs. an imbedded and automated psychology referral for all subjects who screen positive for anxiety or depression.
Detailed Description
SPECIFIC AIMS: Mental Health and Quality of Life in Children with Gastrointestinal Disorders Depression and anxiety are two of the most common and dangerous disorders in childhood and adolescence. Currently, a large proportion of children with these disorders remain unrecognized or untreated resulting in considerable morbidity and mortality. The rates of depression and anxiety are significantly higher in children with chronic illnesses, including gastrointestinal disorders, than in the general population. Furthermore, children with depression or anxiety are far more likely to have somatic complaints, and have greater utilization of subspecialty care, especially in gastroenterology. Functional gastrointestinal disorders such as irritable bowel syndrome, chronic recurrent abdominal pain, and functional dyspepsia frequently have comorbid anxiety or depression. Efforts to recognize and treat mental health problems in children with chronic medical illness, such as gastrointestinal disorders, have been shown to improve adherence to therapy, as well as other clinical outcomes. More importantly, improving such mental health problems might go far to addressing the outcomes patients care about most with respect to their gastroenterological disease. Unfortunately, mental health resources are often difficult for families to access, even when these disorders are recognized. Validated screening tools exist to screen for anxiety and depression in children and adolescents, including the Screen for Childhood Anxiety Related Emotional Disorders (SCARED) and the Patient Health Questionnaire (PHQ-9). Despite the established importance of depression and anxiety in the gastrointestinal health of children and adolescents, few data exist describing the treatment of anxiety and depression by pediatric gastroenterologists. Furthermore, little is known about how families or patients view the subspecialty office as the setting to detect or care for mental illness. Additionally, if anxiety and depression are identified by the gastroenterologist, many practitioners find either they have limited training and expertise in the management of adolescent mental health disorders, or they encounter barriers to referral to a mental health specialist, especially in children with public insurance. Therefore, the specific aims of this research project are to: Aim 1: Determine family and patient attitudes towards tools to screen for mental illness in a pediatric subspecialty office utilizing structured interviews. Sub Aim 1a: Determine patient and family attitudes toward anxiety and depression screening in a subspecialty office. Sub Aim 1b: Determine outcomes of importance to patients and families related to anxiety and depression in a pediatric subspecialty office. Aim 2: Develop an integrated approach that accounts for family and patient preferences as determined in Aim 1, to deliver anxiety and depression screening instruments to new and established patients in a pediatric gastroenterology clinic. Aim 3: Perform a pre-post comparative effectiveness trial comparing screening in a pediatric gastroenterological clinic with notification of the physician to screening in a pediatric gastroenterological clinic with the addition of a psychologist, with respect to the patient-centered outcomes identified in Aim 1. Completion of these aims will allow the investigators to develop an integrated process to screen for depression and anxiety in a high-risk population. Furthermore, the knowledge gained from piloting depression and anxiety screening will help the investigators to determine attitudes towards this approach in the pediatric subspecialty setting, which will maximize outcomes from the visit that are important to patients and their families. The investigators hypothesize that a combined approach that screens for depression and anxiety within the gastroenterology clinic and also provides for access to a psychologist who is integrated with the clinic will lead to superior clinical and patient-centered outcomes. However the investigators may find that screening patients and then alerting the gastroenterology provider may be sufficient to recognize and treat mental health disorders effectively. Comparing the effectiveness of these two strategies is therefore important and is the overall focus of this proposal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Subspecialty Care
Arm Type
Experimental
Arm Description
Once a subject is screened positive for anxiety or depression, the subspecialty provider is informed of the positive screen, and left to manage or refer the condition as per usual care by that provider. Intervention: Depression / anxiety screen + clinician informed.
Arm Title
Integrated Psychology Care
Arm Type
Active Comparator
Arm Description
Once a subject is screened positive for anxiety or depression, an automated psychology referral occurs, in addition to any intervention determined by the subspecialty provider. Intervention: Depression / anxiety screen + clinician informed + automated psychologist visit.
Intervention Type
Other
Intervention Name(s)
Automated Psychology Services
Intervention Description
The automated screening tool determines a positive or negative screen, then informs the clinician, and also automates a psychology visit.
Intervention Type
Other
Intervention Name(s)
Notification of Subspecialist
Intervention Description
The automated screening tool determines a positive or negative screen, then informs the clinician.
Primary Outcome Measure Information:
Title
Quality of life (baseline)
Description
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)
Time Frame
Baseline
Title
Quality of life (followup)
Description
Baseline quality of life measurement will be determined using the PedsQL instrument. Both the general PedsQL instrument and the PedsQL gastroenterology symptom index will be used for baseline and followup measures. PedsQL Minimum score: 0 (Worse outcome) PedsQL Maximum score: 100 (Better outcome)
Time Frame
Within 6 months
Secondary Outcome Measure Information:
Title
Utilization of endoscopy
Description
The investigators will compare the use of endoscopy, radiologic testing, laboratory testing, emergency department utilization, and repeat gastroenterology outpatient visits. Frequency of each of these will be compared between control and intervention arms.
Time Frame
Within 6 months
Title
Utilization of radiologic testing
Description
The electronic medical record will be queried by the RA and the total number of radiologic tests ordered over 6 months will be computed.
Time Frame
6 months
Title
Utilization of laboratory testing
Description
The electronic medical record will be queried by the RA and the total number of laboratory tests ordered over 6 months will be computed.
Time Frame
6 months
Title
Utilization of emergency department visits
Description
The electronic medical record will be queried by the RA and the total number of emergency department visits over 6 months will be computed.
Time Frame
6 months
Title
Utilization of outpatient gastroenterology
Description
The electronic medical record will be queried by the RA and the total number of outpatient gastroenterology visits over 6 months will be computed.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients seen at the pediatric GI office who are screened for anxiety and depression as part of usual care. Exclusion Criteria: Patients over the age of 18 or under the age of 10.
Facility Information:
Facility Name
Indiana University Health North Hospital
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46074
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Detecting and Evaluating Childhood and Anxiety and Depression Effectively in Subspecialties

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